Accurate Multi Panel Drug Urine Test Cup— 510(k) K191841

Name: FDA 510(k) clearance K191841
Creator: U.S. Food and Drug Administration
Published: 2019-08-07

Substantially Equivalent

Healstone Biotech, Inc.

FDA 510(k) clearance K191841 for Accurate Multi Panel Drug Urine Test Cup, Substantially Equivalent on 2019-08-07. Applicant: Healstone Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Healstone Biotech, Inc.
Product code: Code NFT
Device class: Class 2
Regulation: 21 CFR 862.3100
Advisory panel: Clinical Toxicology
Date received: 2019-07-09
Decision date: 2019-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vancouver, CA

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.